Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Last updated: March 3, 2022
Sponsor: Shire
Overall Status: Terminated

Phase

3

Condition

Crohn's Disease

Inflammatory Bowel Disease

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT03627091
SHP647-307
2017-000617-23
  • Ages 16-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants and/or their parent or legally authorized representative (LAR) must havean understanding, ability, and willingness to fully comply with study procedures andrestrictions.
  • Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, toparticipate in the study.
  • Participants must have completed the 16-week induction treatment period from studySHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria atbaseline in maintenance study SHP647-307:
  1. Meet endoscopic response criteria of a reduction in SES-CD from induction studiesSHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than orequal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) orSHP647-306 (NCT03566823) or
  2. Meet at least 1 of the following 4 criteria at baseline in maintenance studySHP647-307, in addition to no worsening of endoscopic score as measured by SES-CDrelative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline:
  • Achieving clinical remission as determined by meeting the criteria for clinicalremission using the 2-item PRO, that is, 2-item PRO sub scores of average worst dailyabdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and averagedaily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shownin the Bristol Stool Form Scale (BSFS) over the 7 most recent days*.
  • A decrease of at least 100 points in CDAI score (CDAI-100) from induction studiesbaseline.
  • A decrease of >=30% and at least 2 points from induction studies baseline in theaverage daily worst abdominal pain over the 7 most recent days*, with the averagedaily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) notworsening from induction studies baseline and/or (ii) meeting the criteria forclinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 mostrecent days*.
  • A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very softstools/liquid stools) as shown in the BSFS over the 7 most recent days*, with theaverage daily worst abdominal pain either: (i) not worsening from induction studiesSHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting thecriteria for clinical remission, that is, 2-item PRO sub score of average worst dailyabdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*. *Note: The 7 days may or may not be contiguous during the 10 days of data collectionbefore colonoscopy preparation, depending on days to be excluded because of missingdata. If fewer than 7 days are available, the criterion will be calculated on allavailable most recent 6 or 5 days. If fewer than 5 days are available, the criterionwill be treated as missing.
  • Participants receiving any treatments for CD are eligible provided they have been, andare anticipated to be, on a stable dose for the designated period of time.

Exclusion

Exclusion Criteria:

  • Participants who had major protocol deviations (as determined by the sponsor) ininduction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who permanently discontinued investigational product because of an AE,regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who are likely to require surgery for CD during the study period, exceptminor interventions (eg, seton placement for anal fistulas).
  • Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who areplanning to become pregnant during the study period, or males or females ofchildbearing potential not agreeing to continue acceptable contraception methods (ie,highly effective methods for female participants and medically appropriate methods formale participants) through the conclusion of study participation.
  • Participants who do not agree to postpone donation of any organ or tissue, includingmale participants who are planning to bank or donate sperm and female participants whoare planning to harvest or donate eggs, for the duration of the study and through 16weeks after last dose of investigational product.
  • Participants who, in the opinion of the investigator or the sponsor, will beuncooperative or unable to comply with study procedures.
  • Participants who have developed obstructive colonic stricture, or enterovesical orenterovaginal fistulae during the induction study SHP647-305 (NCT03559517) orSHP647-306 (NCT03566823).
  • Participants who have a newly diagnosed malignancy or recurrence of malignancy (otherthan resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma insitu of the uterine cervix that has been treated with no evidence of recurrence).
  • Participants who have developed any major illness/condition or evidence of an unstableclinical condition (example [eg,] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg,Felty's syndrome], or local active infection/infectious illness) that, in theinvestigator's judgment, will substantially increase the risk to the participant if heor she participates in the study.
  • Participants with any other severe acute or chronic medical or psychiatric conditionor laboratory or ECG abnormality that may increase the risk associated with studyparticipation or investigational product administration or may interfere with theinterpretation of study results and, in the judgment of the investigator, would makethe participant inappropriate for entry into this study.
  • Participants with known exposure to Mycobacterium tuberculosis (TB) since testing atscreening in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823)and who have been advised to require treatment for latent or active disease but whoare without a generally accepted course of treatment.
  • Participants with any of the following abnormalities in hematology and/or serumchemistry profiles during the evaluation of the last visit in the induction studiesSHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered bythe investigator to be transient and inconsistent with the participant's clinicalcondition, may be repeated once prior to enrollment in Study SHP647-307.
  1. Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × theupper limit of normal (ULN).
  2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a knowndocumented history of Gilbert's syndrome.
  3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
  4. Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).
  5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).
  6. Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)
  7. Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification ofDiet in Renal Disease Study Equation.
  • Note: If platelet count is <150,000 cells/mm^3, a further evaluation shouldbe performed to rule out cirrhosis, unless another etiology has already beenidentified.
  • Participants who are investigational site staff members or relatives of those sitestaff members or participants who are sponsor employees directly involved in theconduct of the study.
  • Participants who are participating in other investigational studies (other thaninduction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan toparticipate in other investigational studies during this study.

Study Design

Total Participants: 40
Study Start date:
February 06, 2019
Estimated Completion Date:
September 13, 2021

Connect with a study center

  • Fundación Favaloro

    Buenos Aires, C1093AAS
    Argentina

    Site Not Available

  • Hospital Privado Centro Médico de Córdoba

    Córdoba,
    Argentina

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Mater Hospital Brisbane

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, Steiermark 8036
    Austria

    Site Not Available

  • Klinikum Wels-Grieskirchen GmbH

    Vienna, Wien A-1090
    Austria

    Site Not Available

  • Salzburger Landeskliniken

    Salzburg, 5020
    Austria

    Site Not Available

  • Medizinische Universitat Wien (Medical University of Vienna)

    Wien, 1090
    Austria

    Site Not Available

  • Academisch Medisch Centrum Amsterdam

    Bonheiden, Antwerpen 2820
    Belgium

    Site Not Available

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk, West-Vlaanderen 8500
    Belgium

    Site Not Available

  • CHU Mouscron

    Mouscron, 7700
    Belgium

    Site Not Available

  • Clinical Center Banja Luka

    Banja Luka, 78000
    Bosnia and Herzegovina

    Site Not Available

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, Sofia-Grad 1784
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Eurohospital

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Medical Center Convex EOOD

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1632
    Bulgaria

    Site Not Available

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1202
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Centre Mladost - M OOD

    Varna, 9000
    Bulgaria

    Site Not Available

  • Fundación Valle Del Lili

    Cali, Valle Del Cauca 760026
    Colombia

    Site Not Available

  • Fundación Valle Del Lili

    Santander, Valle Del Cauca 68276
    Colombia

    Site Not Available

  • IPS Centro Médico Julián Coronel S.A.S. - PPDS

    Cali,
    Colombia

    Site Not Available

  • University Hospital Center Zagreb

    Zagreb, Grad Zagreb 10000
    Croatia

    Site Not Available

  • Opca bolnica Bjelovar

    Bjelovar, 43000
    Croatia

    Site Not Available

  • Clinical Hospital Centre Osijek

    Osijek, 31000
    Croatia

    Site Not Available

  • General Hospital Virovitica

    Virovitica, 33000
    Croatia

    Site Not Available

  • OÜ LV Venter

    Parnu, 80010
    Estonia

    Site Not Available

  • West Tallinn Central Hospital

    Tallinn, 10617
    Estonia

    Site Not Available

  • Klinikum rechts der Isa der Technischen Universitaet Muenchen

    Munich, Bayern 81675
    Germany

    Site Not Available

  • Universitätsklinikum der RWTH Aachen

    Aachen, Nordrhein-Westfalen 52074
    Germany

    Site Not Available

  • Uniklinik Köln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Gastro Campus Research GbR

    Münster, Nordrhein-Westfalen 48159
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitatsklinikum Jena

    Jena, Thüringen 07747
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Gastroenterologische Facharztpraxis am Mexikoplatz

    Berlin-Zehlendorf, 14163
    Germany

    Site Not Available

  • Sana Klinikum Biberach

    Biberach an der Riss, 88400
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt, 60596
    Germany

    Site Not Available

  • Ippokrateio General Hospital of Athens

    Athens, Attiki 11527
    Greece

    Site Not Available

  • University General Hospital of Heraklion

    Heraklion, 71110
    Greece

    Site Not Available

  • Iatriko Palaiou Falirou

    Paliao Faliro, 17562
    Greece

    Site Not Available

  • University General Hospital of Patras

    Patras, 26504
    Greece

    Site Not Available

  • Euromedica - PPDS

    Thessaloniki, 54645
    Greece

    Site Not Available

  • Bekes Megyei Kozponti Korhaz

    Bekescsaba, 5600
    Hungary

    Site Not Available

  • ENDOMEDIX Kft.

    Budapest, 1139
    Hungary

    Site Not Available

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062
    Hungary

    Site Not Available

  • Pannónia Magánorvosi Centrum Kft

    Budapest, 1135
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Mohacsi Korhaz

    Mohacs, 7700
    Hungary

    Site Not Available

  • Tolna Megyei Balassa János Kórház

    Szekszard, 7100
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • St Vincent's University Hospital

    Dublin, 4
    Ireland

    Site Not Available

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 91031
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariya, 22100
    Israel

    Site Not Available

  • Baruch Padeh Poriya Medical Center

    Tiberias, 15208
    Israel

    Site Not Available

  • Azienda Ospedaliera Mater Domini Di Catanzaro

    Catanzaro, Calabria 88100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, Emilia-Romagna 41100
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto 37024
    Italy

    Site Not Available

  • A.O.U. Maggiore della Carità

    Novara, 28100
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100
    Italy

    Site Not Available

  • La Sapienza-Università di Roma-Policlinico Umberto I

    Roma, 00161
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089
    Italy

    Site Not Available

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô 060-8543
    Japan

    Site Not Available

  • Medical Corporation Aoyama Clinic

    Kobe-shi, Hyôgo 650-0015
    Japan

    Site Not Available

  • Hyogo College of Medicine

    Nishinomiya-shi, Hyôgo 663-8501
    Japan

    Site Not Available

  • Jikei University Hospital

    Minato-ku, Tokyo 105-8471
    Japan

    Site Not Available

  • Ome Municipal General Hospital

    Ome, Tokyo 198-0042
    Japan

    Site Not Available

  • Ishida Clinic of IBD and Gastroenterology

    Oita-city, Ôita 870-0823
    Japan

    Site Not Available

  • Kunimoto Hospital

    Asahikawa, 070-0061
    Japan

    Site Not Available

  • Hidaka Coloproctology Clinic

    Kurume-shi, 839-0809
    Japan

    Site Not Available

  • Aichi Medical University Hospital

    Nagakute, 480-1195
    Japan

    Site Not Available

  • Nishinomiya Municipal Central Hospital

    Nishinomiya, 663-8014
    Japan

    Site Not Available

  • Onomichi General Hospital

    Onomichi,
    Japan

    Site Not Available

  • Chiinkai Dojima General & Gastroenterology Clinic

    Osaka, 530-0003
    Japan

    Site Not Available

  • Yodogawa Christian Hospital

    Osaka, 533-0024
    Japan

    Site Not Available

  • Kinshukai Infusion Clinic

    Osaka-shi, 530-0011
    Japan

    Site Not Available

  • Shiga University of Medical Science Hospital

    Otsu-Shi, 520-2192
    Japan

    Site Not Available

  • Toho University Sakura Medical Center

    Sakura, 285-8741
    Japan

    Site Not Available

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033
    Japan

    Site Not Available

  • Sapporo Tokushukai Hospital

    Sapporo-shi, 065-0033
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293
    Japan

    Site Not Available

  • Nihonbashi Egawa Clinic

    Tokyo, 103-0028
    Japan

    Site Not Available

  • Colo-Proctology Center Matsushima Clinic

    Yokohama, 220-0045
    Japan

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Wonju, Gang'weondo 26426
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center, CHA University

    Seongnam, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggido 16247
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, 702-210
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Inje University Seoul Paik Hospital

    Seoul, 04551
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Al Zahraa University Hospital

    Beirut,
    Lebanon

    Site Not Available

  • Hammoud Hospital University Medical Center

    Saida,
    Lebanon

    Site Not Available

  • Vilnius City Clinical Hospital

    Vilnius, LT-10207
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT- 08661
    Lithuania

    Site Not Available

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Zapopan, Jalisco 45030
    Mexico

    Site Not Available

  • Clinica de Higado y Gastroenterologia Integral, S.C.

    Cuernavaca, Morelos 62170
    Mexico

    Site Not Available

  • JM Research S.C

    Cuernavaca, Morelos 62290
    Mexico

    Site Not Available

  • Accelerium, S. de R.L. de C.V.

    Monterrey, Nuevo León 64000
    Mexico

    Site Not Available

  • Unidad de Atencion Medica e Investigacion en Salud

    Merida, Yucatán 97000
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica Acelerada, S.C.

    Distrito Federal, 07020
    Mexico

    Site Not Available

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000
    Mexico

    Site Not Available

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Zapopan, Jalisco, 45030
    Mexico

    Site Not Available

  • ETZ-Elisabeth

    Tilburg, Noord-Brabant 5022 GC
    Netherlands

    Site Not Available

  • NWZ, location Alkmaar

    Den Helder, Noord-Holland 1782 GZ
    Netherlands

    Site Not Available

  • Dunedin Hospital

    Dunedin, South Island 9016
    New Zealand

    Site Not Available

  • Wellington Hospital

    Newtown, Wellington 6021
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3240
    New Zealand

    Site Not Available

  • Lexmedica

    Wroclaw, Dolnoslaskie 53-114
    Poland

    Site Not Available

  • Melita Medical

    Wroclaw, Dolnoslaskie 50-449
    Poland

    Site Not Available

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz, Kujawsko-pomorskie 85-079
    Poland

    Site Not Available

  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

    Torun, Kujawsko-pomorskie 87-100
    Poland

    Site Not Available

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

    Wloclawek, Kujawsko-pomorskie 87-800
    Poland

    Site Not Available

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

    Lódz, Lódzkie 90-647
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

    Lódz, Lódzkie 90-302
    Poland

    Site Not Available

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warszawa, Mazowieckie 04-749
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

    Warszawa, Mazowieckie 03-580
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie 15-276
    Poland

    Site Not Available

  • Endoskopia Sp. z o.o.

    Sopot, Pomorskie 81-756
    Poland

    Site Not Available

  • Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

    Konskie, Swietokrzyskie 26-200
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, Zachodniopomorskie 71-434
    Poland

    Site Not Available

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Centrum Medyczne Czestochowa - PRATIA - PPDS

    Czestochowa, 42-200
    Poland

    Site Not Available

  • Centrum Medyczne Gdynia - PRATIA - PPDS

    Gdynia, 81-338
    Poland

    Site Not Available

  • NZOZ All Medicus

    Katowice, 40-660
    Poland

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338
    Poland

    Site Not Available

  • Med Gastr Sp.z.o.o Sp.k

    Lodz, 91-034
    Poland

    Site Not Available

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100
    Poland

    Site Not Available

  • Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa

    Poznan, 60-848
    Poland

    Site Not Available

  • Centrum Medyczne Warszawa - PRATIA - PPDS

    Rzeszow, 35-068
    Poland

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Site Not Available

  • Sonomed Sp. z o.o.

    Szczecin, 71-685
    Poland

    Site Not Available

  • Centrum Zdrowia M D M

    Warsaw,
    Poland

    Site Not Available

  • BioVirtus Centrum Medyczne

    Warszawa, 02-797
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSW

    Warszawa, 02-507
    Poland

    Site Not Available

  • Centrum Zdrowia M D M

    Warszawa, 00-635
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

    Zamosc, 22-400
    Poland

    Site Not Available

  • Hospital Senhora da Oliveira - Guimaraes, E.P.E

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • Hospital da Luz

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimão, 8500-338
    Portugal

    Site Not Available

  • Sana Monitoring SRL

    Bucharest, Bucuresti 011025
    Romania

    Site Not Available

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca, Cluj 400006
    Romania

    Site Not Available

  • Colentina Clinical Hospital

    Bucharest, 020125
    Romania

    Site Not Available

  • Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest, 010825
    Romania

    Site Not Available

  • Emergency University Hospital

    Bucharest, 050098
    Romania

    Site Not Available

  • Fundeni Clinical Institute

    Bucharest, 022328
    Romania

    Site Not Available

  • Prof. Dr. Matei Bals Institute of Infectious Diseases

    Bucharest, 021105
    Romania

    Site Not Available

  • Centrul Medical Hifu Terramed Conformal S.R.L.

    Bucuresti, 031864
    Romania

    Site Not Available

  • Affidea Romania SRL

    Constanta, RO-900591
    Romania

    Site Not Available

  • Gastromedica SRL

    Iasi, 700506
    Romania

    Site Not Available

  • Dr. Tirnaveanu Amelita Private Practice

    Oradea, 410066
    Romania

    Site Not Available

  • Dr. Goldis Gastroenterology Center SRL

    Timisoara, 300002
    Romania

    Site Not Available

  • Rostov State Medical University

    Rostov-on-Don, 344091
    Russian Federation

    Site Not Available

  • Russian Medical Military Academy n.a. S.M. Kirov

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Medical University Reaviz

    Samara, 443011
    Russian Federation

    Site Not Available

  • Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

    Samara, 443029
    Russian Federation

    Site Not Available

  • SHI Regional Clinical Hospital

    Saratov, 410012
    Russian Federation

    Site Not Available

  • St. Elizabeth Municipal Clinical Hospital

    St. Petersburg, 195067
    Russian Federation

    Site Not Available

  • University Clinical Center Kragujevac

    Kragujevac, Šumadijski Okrug 34000
    Serbia

    Site Not Available

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080
    Serbia

    Site Not Available

  • University Clinical Center Nis

    Nis, 18000
    Serbia

    Site Not Available

  • General Hospital Vrsac

    Vrsac, 26300
    Serbia

    Site Not Available

  • Clinical Hospital Center Zemun

    Zemun,
    Serbia

    Site Not Available

  • KM Management, spol. s r.o.

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Gastro LM, s.r.o.

    Presov, 080 01
    Slovakia

    Site Not Available

  • CLINRESCO, ARWYP Medical Suites

    Johannesburg, Gauteng 1619
    South Africa

    Site Not Available

  • Dr. J Breedt

    Pretoria, Gauteng 0084
    South Africa

    Site Not Available

  • Dr JP Wright

    Claremont, Western Cape 7708
    South Africa

    Site Not Available

  • C.H. Regional Reina Sofia - PPDS

    Cordoba, Córdoba 14004
    Spain

    Site Not Available

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid 28942
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, Madrid, Communidad Delaware 28007
    Spain

    Site Not Available

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra 36312
    Spain

    Site Not Available

  • Centro Medico Teknon - Grupo Quironsalud

    Barcelona, 08022
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - PPDS

    Sevilla, 41013
    Spain

    Site Not Available

  • Mersin University Medical Faculty

    Mersin, 33169
    Turkey

    Site Not Available

  • Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

    Chernivtsi, Chernivets'ka Oblast 58001
    Ukraine

    Site Not Available

  • Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council

    Kharkiv, Kharkivs'ka Oblast 61037
    Ukraine

    Site Not Available

  • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, Kyïv 04107
    Ukraine

    Site Not Available

  • LLC Medical Center Family Medicine Clinic

    Dnipro, 49038
    Ukraine

    Site Not Available

  • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058
    Ukraine

    Site Not Available

  • Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

    Kherson, 73000
    Ukraine

    Site Not Available

  • Medical Center OK!Clinic+LLC International Institute of Clinical Research

    Kyiv, 02091
    Ukraine

    Site Not Available

  • Medical Center of LLC Medical Center Dopomoga-Plus

    Kyiv, 02132
    Ukraine

    Site Not Available

  • Medical Center of LLC Medical Clinic Blagomed

    Kyiv, 01023
    Ukraine

    Site Not Available

  • Municipal Institution of KRC Kyiv Regional Hospital #2

    Kyiv, 04073
    Ukraine

    Site Not Available

  • Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

    Lviv, 79059
    Ukraine

    Site Not Available

  • Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

    Vinnytsia, 21029
    Ukraine

    Site Not Available

  • MNPE City Hospital No. 6 of Zaporizhzhia City Council

    Zaporizhzhia, 69035
    Ukraine

    Site Not Available

  • North Tyneside General Hospital

    North Shields, Northumberland NE29 8NH
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, AB25 2ZN
    United Kingdom

    Site Not Available

  • Royal Gwent Hospital - PPDS

    Newport, NP20 2UB
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Arizona Digestive Health Mesa - East

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Elite Clinical Studies - Phoenix - Clinedge - PPDS

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • CATS Research Center - University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Atria Clinical Research - Clinedge - PPDS

    Little Rock, Arkansas 72209
    United States

    Site Not Available

  • Advanced Research Center

    Anaheim, California 92805
    United States

    Site Not Available

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California 92879
    United States

    Site Not Available

  • OM Research LLC - Lancaster - ClinEdge - PPDS

    Lancaster, California 93534
    United States

    Site Not Available

  • Alliance Clinical Research-(Vestavia Hills)

    Poway, California 92064
    United States

    Site Not Available

  • Inland Empire Liver Foundation

    Rialto, California 92377
    United States

    Site Not Available

  • Care Access Research, San Pablo

    San Pablo, California 94806
    United States

    Site Not Available

  • Asthma and Allergy Associates PC - CRN - PPDS

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80903
    United States

    Site Not Available

  • Renaissance Research Medical Group, INC

    Cape Coral, Florida 33991
    United States

    Site Not Available

  • Gastro Florida

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Advanced Clinical Research Network

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Alliance Medical Research LLC

    Coral Springs, Florida 33071
    United States

    Site Not Available

  • SIH Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Hi Tech and Global Research, LLc

    Miami, Florida 33135
    United States

    Site Not Available

  • Sanchez Clinical Research, Inc

    Miami, Florida 33157
    United States

    Site Not Available

  • Crystal Biomedical Research

    Miami Lakes, Florida 33065
    United States

    Site Not Available

  • Gastroenterology Group of Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • Pharma Research International Inc

    Naples, Florida 34110
    United States

    Site Not Available

  • Omega Research Consultants LLC - Clinedge - PPDS

    Orlando, Florida 32810
    United States

    Site Not Available

  • Accel Research Sites - St. Petersburg - ERN - PPDS

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • DBC Research

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Bayside Clinical Research - New Port Richey

    Tampa, Florida 33604
    United States

    Site Not Available

  • Atlanta Gastroenterology Specialists, PC

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Infinite Clinical Trials

    Atlanta, Georgia 30349
    United States

    Site Not Available

  • Atlanta Center For Gastroenterology PC

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Loretto Hospital

    Chicago, Illinois 60644
    United States

    Site Not Available

  • IL Gastroenterology Group

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Laporte County Institute For Clinical Research

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • CroNOLA, LLC.

    Houma, Louisiana 70360
    United States

    Site Not Available

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • DelRicht Clinical Research, LLC - ClinEdge - PPDS

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Louisiana Research Center LLC

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Commonwealth Clinical Studies LLC

    Brockton, Massachusetts 02302
    United States

    Site Not Available

  • Winchester Gastroenterology Associates

    Winchester, Massachusetts 22601
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • National Clinical, LLC

    Hamtramck, Michigan 48212
    United States

    Site Not Available

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Mayo Clinic Health System - PPDS

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Minnesota Gastroenterology PA

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Minnesota Gastroenterology PA

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Advanced Biomedical Research of America

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • Encompass Care

    North Las Vegas, Nevada 89086
    United States

    Site Not Available

  • New York Total Medical Care PC

    Brooklyn, New York 11215
    United States

    Site Not Available

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York 11021
    United States

    Site Not Available

  • Southtowns Gastroenterology, PLLC

    Orchard Park, New York 14127
    United States

    Site Not Available

  • Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Consultants For Clinical Research Inc

    Fairfield, Ohio 45014
    United States

    Site Not Available

  • Penn State Hershey Medical Group

    State College, Pennsylvania 16803
    United States

    Site Not Available

  • Digestive Disease Associates

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Advanced Gastroenterology-Union City

    Union City, Tennessee 38261
    United States

    Site Not Available

  • Northside Gastroenterology

    Cypress, Texas 77429
    United States

    Site Not Available

  • Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

    Garland, Texas 75044
    United States

    Site Not Available

  • BI Research Center

    Houston, Texas 77084
    United States

    Site Not Available

  • Biopharma Informatic Inc.

    Houston, Texas 77043
    United States

    Site Not Available

  • Precision Research Institute, LLC

    Houston, Texas 77039
    United States

    Site Not Available

  • Southwest Clinical Trials

    Houston, Texas 77074
    United States

    Site Not Available

  • Southern Star Research Institute LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS

    Webster, Texas 77598
    United States

    Site Not Available

  • HP Clinical Research

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Mid Atlantic Health Specialists

    Galax, Virginia 24333
    United States

    Site Not Available

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